Personalized, Biodegradable Implants for Bone Reconstructive Surgery

Our expertise is in the production of clinically validated, personalized, biodegradable anatomical spatial structures used in the design of bone medical implants for applications in neurosurgical, cranial and craniofacial reconstructions. The proposed solution addresses the current limitations through the use of implants tailored to anatomical characteristics and made of a biodegradable polymer of polylactide (PLA) or its derivatives. It is also possible to tune the time of resorption of the implant material to align with the process of bone tissue remodelling and rebuilding. The proposed technological solution allows for the production of spatial structures for biomedical engineering applications such as personalized facial implants and skull vaults made to order by a surgeon for a particular paediatric patient.

This technology is able to develop a product based on "fast prototyping", which aims to manufacture individualized, implantable and biodegradable medical devices from composite and biocompatible materials. Medical devices will be manufactured using the following methods:

1) injection,

2) incremental technology – 3D printing,

3) solution method in individual form.

With our core technology, several dozen medical devices (implants) can be designed and manufactured on order per day.

The following people are direct recipients of the project:

• after craniocerebral injuries (e.g. car accidents, injuries, etc.),
• after oncological supply (e.g. after resection of tumours of the central nervous system),
• with a cerebral hernia,
• after hemicranectomy,
• with osteomas of the skull,
• after surgical interventions in the craniofacial region and skull vaults,
• with birth defects that can be helped with the use of plastic surgery,
• with the need to make corrections or supplements to bone tissue in dental reconstructions.

Most of the above reconstructions in the area of the skull vault are for protecting the brain, restoring the outline of the skull and normalization of cerebral hemodynamics. The developed technologies may also be used for other applications requiring individual and accurate design of a complicated implant, e.g. the spine. 

With the progress in materials used in regenerative medicine, especially in supplementing bone defects, users will need to consider the shaping of new materials into their desired form. This is especially true for bioresorbable materials. It is also necessary to preserve their physicochemical properties – porosity. Materials available on the market are delivered in standardized shapes. Their adjustment to the bone defect during surgery requires additional skills from the doctor, extends the duration of the procedure and is at high risk of error in treatment. In addition, there are no dedicated tools, and the aesthetic effect is also problematic. Hence, the lack of technology for shaping such materials is a barrier to the dissemination of modern medical materials. Also, from the patient's point of view, post-operative aesthetics is extremely important. There is also growing importance of personalized (personal) medicine for individual patients. It is estimated that in the next 10 years, up to 50% of therapies will be personalized, of which nearly 80% in oncology.

1. The use of bio-resorbable implants will reduce the patient's psychological burden caused by traumatic surgical procedures, improve the actual procedures and shorten the hospitalization period.

2. On the other hand, the hospital and the doctor can expect a reduction in costly medical procedures, e.g. re-surgery to remove non-resorbable implants (medical steel and other medical alloys, porous polyethylene, PEEK, PMMA, polypropylene-polyester textile composites, etc.).

3. Personalized therapy at a competitive price.